Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 648 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 160 mg/kg bw

Additional information

Oral

Isodecanol was administered via oral gavage to 5 male rats at doses of 31.6, 100, 316, 1000, 3160 or 10000 ul/kg (26.4, 83.8, 264, 838, 2648, or 8380 mg/kg respectively) to assess acute oral toxicity.  Clinical observations were made at 1, 4, and 24 hours and daily thereafter for 7 days post exposure. All animals in the 10000 ul/kg (8380 mg/kg) dose group died within 4 hours of exposure. All other animals survived, but exhibited signs of depression at 4 hours; characterized by inactivity, labored respiration, ataxia, and sprawling of the limbs. At 24 hours, the animals that survived appeared to be acting normally. At the end of the study, it was concluded that the LD50 >2648 mg/kg.

 

Inhalation

Isodecanol was administered as a vapor to 10 male mice, rats, and guinea pigs at the theoretical concentration of 95.3 ppm for 6 hours.  During the exposure period all animals were observed for gross signs of toxicity every 30 minutes.  Thirty minutes after the initiation of the exposure, mice and rats exhibited blinking and redness around the nostril; eventually signs of nasal discharge and salivation were observed and persisted throughout the experiment.  All animals appeared normal within 30 minutes after termination of the exposure.   At the end of the study, the LC50 was > 95.3 ppm.

 

Dermal

The dermal toxicity and irritative properties of isodecanol were evaluated in rabbits exposed to 100, 316, 1000 or 3160 ul/kg (83.8, 264, 838, or 2648 mg/kg) via an occluded patch for 24 hours.  The animals were observed for gross effects at 1, 4, and 24 hours after application and once daily thereafter for 7 days.  All animals survived dosing. Most animals exhibited slight signs of dermal irritation with severity increasing in a dose-related manner.  Most signs of dermal irritation were resolved within 1-3 days in the two lower dose groups.  At the time of sacrifice the exposed skin area of all animals generally showed atonia and desquamation.  In addition, the animals at the 3160, ul/kg level showed blanched areas, necrotic areas, and a coriaceous condition. It is concluded that the LD50 is greater then 3160 ul/kg.

Justification for classification or non-classification

No classification for acute toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.